Clinical Trials /

Phase I Trial HIPEC With Nal-irinotecan



The purpose of this study is to assess the effectiveness and safety of intraperitoneal administration of heated nanoliposomal Irinotecan in cytoreductive surgery (CRS), which is surgery designed to remove as much of the cancer as possible, and heated intraperitoneal chemotherapy (HIPEC) procedures.

Related Conditions:
  • Colorectal Carcinoma
  • Gastric Carcinoma
  • Mucinous Adenocarcinoma
  • Peritoneal Malignant Mesothelioma
  • Primary Peritoneal Carcinoma
  • Pseudomyxoma Peritonei
Recruiting Status:



Phase 1

Trial Eligibility



  • Brief Title: Phase I Trial HIPEC With Nal-irinotecan
  • Official Title: Phase I Trial of Cytoreductive Surgery and Heated Intraperitoneal Chemotherapy With Nanoliposomal Irinotecan in Patients With Peritoneal Surface Malignancies

Clinical Trial IDs

  • ORG STUDY ID: 2019-00059 HIPEC Nal-IRI
  • NCT ID: NCT04088786


  • Peritoneal Cancer
  • Pseudomyxoma Peritonei
  • Mucinous Adenocarcinoma
  • Mucinous Tumor
  • Colorectal Cancer
  • Gastric Cancer
  • Primary Peritoneal Carcinoma
  • Mesothelioma


nanoliposomal irinotecanActive


The purpose of this study is to assess the effectiveness and safety of intraperitoneal administration of heated nanoliposomal Irinotecan in cytoreductive surgery (CRS), which is surgery designed to remove as much of the cancer as possible, and heated intraperitoneal chemotherapy (HIPEC) procedures.

Detailed Description

      Cytoreductive surgery and heated intraperitoneal chemotherapy consists of two parts: the
      first is the surgical removal of all grossly visible deposits of cancer from the abdomen; and
      the second is application of heated chemotherapy in salt water at the same time as the
      removal of the visible cancer. HIPEC is an alternative method of delivering chemotherapy.
      Traditional chemotherapy is injected into a vein, while HIPEC applies chemotherapy drugs
      warmed up by an FDA-approved machine to 108 degrees Fahrenheit directly into the abdomen
      during surgery, making it an option for cancers that originated in or have spread to the
      abdominal cavity. Standard treatment in this manner usually includes Mitomycin C or Cisplatin
      as its chemotherapy agents. In this study, the investigators will use nanoliposomal
      irinotecan as the chemotherapy agent. Irinotecan is FDA approved for the treatment of
      pancreatic cancer.

Trial Arms

ActiveExperimentalCytoreductive surgery (CRS) followed by study treatment with nanoliposomal irinotecan administered intraperitoneally.
  • nanoliposomal irinotecan

Eligibility Criteria

        Inclusion Criteria:

          1. Patients with pseudomyxoma peritonei or peritoneal carcinomatosis of digestive origin
             or primary peritoneum: appendiceal mucinous tumor or adenocarcinoma (including goblet
             cell cancer and signet ring cell cancer), colorectal cancer, gastric cancer, primary
             peritoneal adenocarcinoma, and mesothelioma, regardless of the number of prior
             treatment lines. Clinical diagnosis is required prior to surgery and pathologic
             diagnosis of peritoneal surface disease must be confirmed from surgical pathology.

          2. Age ≥18 years

          3. Eastern Cooperative Oncology Group performance status of 0 or 1

          4. Patients must be candidates for grossly complete cytoreduction surgery with life
             expectancy greater than 3 months

          5. Patients must have normal organ and marrow function as defined below:

               -  absolute neutrophil count >1,500/microliter (mcL) and white blood cells >

               -  platelets >75,000/microliters

               -  total bilirubin < 3x upper limit normal for institutional limits

               -  aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) <2.5x
                  institutional upper limit of normal

               -  creatinine within normal institutional limits

          6. Documentation of measurable disease by radiographic peritoneal carcinomatosis index
             (PCI) score and RECIST criteria with preoperative measurements taken within 4 weeks of
             study entry. Presence of measurable disease is required for entry into this study.

          7. Women of child-bearing potential and men must agree to use adequate contraception
             (barrier or hormonal plus barrier method of birth control; abstinence) prior to study
             entry and for the duration of study participation (at least first 6 months). Should a
             woman become pregnant or suspect she is pregnant while participating in this study,
             she should inform her treating physician immediately.

          8. Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          1. Patients with peritoneal disease considered to be unresectable according to
             preoperative clinical criteria.

          2. Patients who undergo debulking for palliation with persistence of gross residual
             disease (complete of cytoreduction score 3, CC=3) will be ineligible for the study.

          3. Large burden visceral metastases or extra-abdominal metastases.

          4. Patients who have had radiotherapy within 4 weeks prior to entering the study or those
             who have not recovered from adverse events due to agents administered more than 4
             weeks earlier. There is no limit on the number of prior lines of chemotherapy.

          5. Patients may not be receiving any other investigational agents.

          6. History of allergic reactions to nal-IRI or irinotecan.

        7 Uncontrolled ongoing illness including, but not limited to, ongoing or active infection,
        symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or
        psychiatric illness/social situations that would limit compliance with study requirements.

        8 Pregnant or breast-feeding women are excluded from this study.

        9 HIV-positive patients on combination antiretroviral therapy are ineligible because of the
        potential for pharmacokinetic interactions. In addition, these patients are at increased
        risk of lethal infections when treated with marrow-suppressive therapy.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame:Up to 12 weeks post surgery
Safety Issue:
Description:To assess the safety and feasibility of administering nanoliposmal irinotecan intraperitoneally following cytoreductive surgery.

Secondary Outcome Measures

Measure:Plasmatic dosages
Time Frame:48 hours
Safety Issue:
Description:Determine the correlation of intraperitoneal dosages of nanoliposomal irinotecan with plasma blood levels using pharmacokinetic analysis
Measure:Disease free survival
Time Frame:every 3-6 month until disease progression
Safety Issue:
Description:Assess the efficacy of intraperitoneal administration of nanoliposomal irinotecan relating to disease free survival.


Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Stony Brook University

Trial Keywords

  • nal-irinotecan

Last Updated

December 1, 2020